1. Field of the Invention
The present invention is directed to a non-invasive stimulation device for activation of Brown Adipose Tissue (BAT) in a supraclavicular fossa region (as defined below) of the human body. Furthermore, the present invention also relates to a methodology for proper positioning of at least a portion of the patch within the supraclavicular fossa region to stimulate the sympathetic nerves and thereby activate a BAT deposit therein.
2. Description of Related Art
Obesity is becoming a growing concern, particularly in the United States, as the number of people with obesity continues to increase and more is learned about the negative health effects of obesity. Severe obesity, in which a person is 100 pounds or more over ideal body weight, in particular poses significant risks for severe health problems. Accordingly, a great deal of attention is being focused on treating obese patients.
Surgical procedures to treat severe obesity have included various forms of gastric and intestinal bypasses (stomach stapling), biliopancreatic diversion, adjustable gastric banding, vertical banded gastroplasty, gastric plications, and sleeve gastrectomies (removal of all or a portion of the stomach). Such surgical procedures have increasingly been performed laparoscopically. Reduced postoperative recovery time, markedly decreased post-operative pain and wound infection, and improved cosmetic outcome are well established benefits of laparoscopic surgery, derived mainly from the ability of laparoscopic surgeons to perform an operation utilizing smaller incisions in the body cavity wall. However, such surgical procedures risk a variety of complications during surgery, pose undesirable post-operative consequences such as pain and cosmetic scarring, and often require lengthy periods of patient recovery. Patients with obesity thus rarely seek or accept surgical intervention, with only about 1% of patients with obesity being surgically treated for this disorder. Furthermore, even if successfully performed and initial weight loss occurs, surgical intervention to treat obesity may not result in lasting weight loss, thereby requiring additional different obesity treatment.
Nonsurgical procedures for treating obesity have also been developed. However, effective therapies for increasing energy expenditure leading to improvements in metabolic outcomes, e.g., weight loss, have focused on pharmaceutical approaches, which have various technical and physiological limitations.
It has been recognized in, for example, U.S. Pat. No. 6,645,229, filed Dec. 20, 2000, entitled “Slimming Device”, which is herein incorporated by reference, that brown adipose tissue (BAT) plays a role in the regulation of energy expenditure and that stimulating BAT can result in patient slimming. BAT activation is regulated by the sympathetic nervous system and other physiological, e.g., hormonal and metabolic, influences. When activated, BAT removes free fatty acids (FFA) and oxygen from the blood supply for the generation of heat. The oxidative phosphorylation cycle that occurs in the mitochondria of activated BAT is shown and described in U.S. Pat. No. 6,645,229.
Accordingly, there is a need for improved methods and devices for treating obesity and in particular for activating BAT. The present invention focuses on activation of BAT via external electrical stimulation of sympathetic nerves innervating BAT and/or the brown adipocytes directly. It is desirable to develop a system and method for proper self-positioning of a transdermal electrical stimulation patch for activation of a target BAT depot within the human body. Furthermore, it is also desirable for the transdermal electrical stimulation patch to be relatively inexpensive, require minimal instruction, able to be self-administered without requiring assistance from a third person and be consistently accurate in its proper placement on the human body.